Robot-assisted early mobilization of intensive care patients: a feasibility study protocol

Angelika Warmbein, Ines Schroeder, Amrei Mehler-Klamt, Ivanka Rathgeber, Jana Huber, Christina Scharf, Lucas Hübner, Marcus Gutmann, Johanna Biebl, Andreas Lorenz, Eduard Kraft, Michael Zoller, Inge Eberl, Uli Fischer, Angelika Warmbein, Ines Schroeder, Amrei Mehler-Klamt, Ivanka Rathgeber, Jana Huber, Christina Scharf, Lucas Hübner, Marcus Gutmann, Johanna Biebl, Andreas Lorenz, Eduard Kraft, Michael Zoller, Inge Eberl, Uli Fischer

Abstract

Background: Early mobilization positively influences the outcome of critically ill patients, yet in clinical practice, the implementation is sometimes challenging. In this study, an adaptive robotic assistance system will be used for early mobilization in intensive care units. The study aims to evaluate the experience of the mobilizing professionals and the general feasibility of implementing robotic assistance for mobilization in intensive care as well as the effects on patient outcomes as a secondary outcome.

Methods: The study is single-centric, prospective, and interventional and follows a longitudinal study design. To evaluate the feasibility of robotic-assisted early mobilization, the number of patients included, the number of performed VEM (very early mobilization) sessions, and the number and type of adverse events will be collected. The behavior and experience of mobilizing professionals will be evaluated using standardized observations (n > 90) and episodic interviews (n > 36) before implementation, shortly after, and in routine. Patient outcomes such as duration of mechanical ventilation, loss of muscle mass, and physical activity will be measured and compared with a historical patient population. Approximately 30 patients will be included.

Discussion: The study will provide information about patient outcomes, feasibility, and the experience of mobilizing professionals. It will show whether robotic systems can increase the early mobilization frequency of critically ill patients. Within ICU structures, early mobilization as therapy could become more of a focus. Effects on the mobilizing professionals such as increased motivation, physical relief, or stress will be evaluated. In addition, this study will focus on whether current structures allow following the recommendation of mobilizing patients twice a day for at least 20 min.

Trial registration: ClinicalTrials.gov, NCT05071248 . Date: 2021/10/21.

Keywords: Care, Nursing; Early mobilization; Feasibility study; Robotics; Unit, Intensive care.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Training of a robot-assisted mobilization (University Hospital LMU Munich 2020)

References

    1. Bailey P, Thomsen GE, Spuhler VJ, Blair R, Jewkes J, Bezdjian L, et al. Early activity is feasible and safe in respiratory failure patients. Crit Care Med. 2007;35(1):139–145. doi: 10.1097/01.CCM.0000251130.69568.87.
    1. Thomsen GE, Snow GL, Rodriguez L, Hopkins RO. Patients with respiratory failure increase ambulation after transfer to an intensive care unit where early activity is a priority. Crit Care Med. 2008;36(4):1119–1124. doi: 10.1097/CCM.0b013e318168f986.
    1. Morris PE, Goad A, Thompson C, Taylor K, Harry B, Passmore L, et al. Early intensive care unit mobility therapy in the treatment of acute respiratory failure. Crit Care Med. 2008;36(8):2238–2243. doi: 10.1097/CCM.0b013e318180b90e.
    1. Burtin C, Clerckx B, Robbeets C, Ferdinande P, Langer D, Troosters T, et al. Early exercise in critically ill patients enhances short-term functional recovery. Crit Care Med. 2009;37(9):2499–2505. doi: 10.1097/CCM.0b013e3181a38937.
    1. Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, et al. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009;373(9678):1874–1882. doi: 10.1016/S0140-6736(09)60658-9.
    1. Connolly B, O'Neill B, Salisbury L, Blackwood B. Physical rehabilitation interventions for adult patients during critical illness: an overview of systematic reviews. Thorax. 2016;71(10):881–890. doi: 10.1136/thoraxjnl-2015-208273.
    1. Reid J, Unger J, McCaskell D, Childerhose L, Zorko DJ, Kho ME. Physical rehabilitation interventions in the intensive care unit: a scoping review of 117 prospective studies. J Intensive Care. 2018;6(8):1–12.
    1. Beyer J, Seidel EJ. Frührehabilitation ist erstes Glied einer nahtlosen Rehabilitationskette. Rehabilitation (Stuttg) 2017;56(4):272–285. doi: 10.1055/s-0043-112071.
    1. Hermans G, De Jonghe B, Bruyninckx F, Van den Berghe G. Interventions for preventing critical illness polyneuropathy and critical illness myopathy. Cochrane Database Syst Rev. 2014;2014(1):CD006832. 10.1002/14651858.CD006832.pub3.
    1. Herridge MS, Tansey CM, Matté A, Tomlinson G, Diaz-Granados N, Cooper A, et al. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011;364(14):1293–1304. doi: 10.1056/NEJMoa1011802.
    1. Eggmann S, Verra ML, Luder G, Takala J, Jakob SM. Effects of early, combined endurance and resistance training in mechanically ventilated, critically ill patients: a randomised controlled trial. PLoS One. 2018;13(11):e0207428. doi: 10.1371/journal.pone.0207428.
    1. Diserens K, Moreira T, Hirt L, Faouzi M, Grujic J, Bieler G, et al. Early mobilization out of bed after ischaemic stroke reduces severe complications but not cerebral blood flow: a randomized controlled pilot trial. Clin Rehabil. 2012;26(5):451–459. doi: 10.1177/0269215511425541.
    1. Barber EA, Everard T, Holland AE, Tipping C, Bradley SJ, Hodgson CL. Barriers and facilitators to early mobilisation in intensive care: a qualitative study. Aust Crit Care. 2015;28(4):177–182. doi: 10.1016/j.aucc.2014.11.001.
    1. Bein T, Bischoff M, Brückner U, Gebhardt K, Henzler D, Hermes C, et al. Kurzversion S2e-Leitlinie - "Lagerungstherapie und Frühmobilisation zur Prophylaxe oder Therapie von pulmonalen Funktionsstörungen". Anaesthesist. 2015;64(8):596–611. doi: 10.1007/s00101-015-0060-4.
    1. Dubb R, Nydahl P, Hermes C, Schwabbauer N, Toonstra A, Parker AM, et al. Barriers and strategies for early mobilization of patients in intensive care units. Ann Am Thorac Soc. 2016;13(5):724–730. doi: 10.1513/AnnalsATS.201509-586CME.
    1. Winkelman C, Peereboom K. Staff-perceived barriers and facilitators. Crit Care Nurse. 2010;30(2):13–16. doi: 10.4037/ccn2010393.
    1. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. Int J Nurs Stud. 2013;50(5):587–92. doi: 10.1016/j.ijnurstu.2012.09.010.
    1. Tipping C, et al. The ICU mobility scale has construct and predictive validity and is responsive: a multicenter observational study. Ann Am Thorac Soc. 2016;13(6):887–893. doi: 10.1513/AnnalsATS.201510-717OC.
    1. Tabachnick BG, Fidell LS. Using multivariate statistics. 6th ed. Boston: Pearson; 2014.
    1. Kinney AR, Eakman AM, Graham JE. Novel effect size interpretation guidelines and an evaluation of statistical power in rehabilitation research. Arch Phys Med Rehabil. 2020;101(12):2219–2226. doi: 10.1016/j.apmr.2020.02.017.
    1. Shea JD. Pressure sores: classification and management. Clin Orthop Relat Res. 1975;112:89–100. doi: 10.1097/00003086-197510000-00012.
    1. Lamneck S, Krell C. Qualitative Sozialforschung: mit Online-Material. 6th ed. Weinheim: Beltz; 2016.
    1. Mehnert A, Müller D, Lehmann C, Koch U. Die deutsche Version des NCCN Distress-Thermometers. Z Psychiatr Psychol Psychother. 2006;54(3):213–223.
    1. Häder M. Empirische Sozialforschung: Eine Einführung. ed. Wiesbaden: Springer VS; 2019.
    1. Hodgson CL, et al. Expert consensus and recommendations on safety criteria for active mobilization of mechanically ventilated critically ill adults. Crit Care. 2014;18(6):658. doi: 10.1186/s13054-014-0658-y.
    1. Rocca A, Pignat J-M, Berney L, et al. Sympathetic activity and early mobilization in patients in intensive and intermediate care with severe brain injuries: a preliminary prospective randomized study. BMC Neurol. 2016;16(1):169. doi: 10.1186/s12883-016-0684-2.
    1. Clarissa C, Salisbury L, Rodgers S, Kean S. Early mobilisation in mechanically ventilated patients: a systematic integrative review of definitions and activities. J Intensive Care. 2019;7(3) Available from: URL: . [Cited 2021 Mar 10].
    1. Doig GS, Simpson F. Randomization and allocation concealment: a practical guide for researchers [discussion 191-3] J Crit Care. 2005;20(2):187–191. doi: 10.1016/j.jcrc.2005.04.005.
    1. Parry SM, Denehy L, Beach LJ, et al. Functional outcomes in ICU – what should we be using?: an observational study. Crit Care. 2015;19(19):127. doi: 10.1186/s13054-015-0829-5.
    1. Tarlov AR, et al. The Medical Outcomes Study: an application of methods for monitoring the results of medical care. JAMA. 1989;262(7):925–930. doi: 10.1001/jama.1989.03430070073033.
    1. Lichtenstein DA, Meziere GA. Relevance of lung ultrasound in the diagnosis of acute respiratory failure: the BLUE protocol. Chest. 2008;134(1):117–125. doi: 10.1378/chest.07-2800.
    1. Francis CA, Hoffer JA, Reynolds S. Ultrasonographic evaluation of diaphragm thickness during mechanical ventilation in intensive care patients. Am J Crit Care. 2016;25(1):e1–e8. doi: 10.4037/ajcc2016563.
    1. Matamis D, et al. Sonographic evaluation of the diaphragm in critically ill patients: technique and clinical applications. Intensive Care Med. 2013;39(5):801–810. doi: 10.1007/s00134-013-2823-1.
    1. Seymour JM, et al. Ultrasound measurements of rectus femoris cross-sectional area and the relationship with quadriceps strength in COPD. Thorax. 2009;64(5):418–423. doi: 10.1136/thx.2008.103986.
    1. Mayring P. Qualitative Inhaltsanalyse. Basel: Beltz; 2015.
    1. Thierbach C, Petschick G. Beobachtung. In: Baur N, Blasius J, editors. Handbuch Methoden der empirischen Sozialforschung. 2nd ed. Wiesbaden: Springer VS; 2019.
    1. Calabrò RS, et al. Do Post-stroke Patients Benefit from Robotic Verticalization? A Pilot-study Focusing on a Novel Neurophysiological Approach. Restor Neurol Neurosci. 2015. 10.3233/RNN-140475.

Source: PubMed

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